国家食品药品监督管理局国家药品标准修订——注射用氟氯西林钠

本品为氟氯西林钠的无菌粉末。按无水物计算,含氟氯西林(C₁₉H₁₇ClFN₃O₅S)不得少于91.0%;按平均装量计算,含氟氯西林(C₁₉H₁₇ClFN₃O₅S)应为标示量的95.0%~105.0%。     

国家食品药品监督管理局国家药品标准修订——注射用萘夫西林钠

本品为萘夫西林钠的无菌粉末。按无水物计算,含萘夫西林(C₂₁H₂₂N₂O₅S)不得少于85.5%;按平均装量计算,含萘夫西林(C₂₁H₂₂N₂O₅S)应为标示量的90.0%~110.0%。     

国家食品药品监督管理局国家药品标准修订——氟氯西林钠

本品为(2S,5R,6R)-6-[[[3-(2-氯-6-氟苯基)-5-甲基异噁唑-4-基]羰基]氨基]-3,3-二甲基-7-氧代-4-硫杂-1-氮杂二环[3.2.0]庚烷-2-甲酸钠一水合物。按无水物计算,含氟氯西林(C₁₉H₁₇ClFN₃O₅S)不得少于91.0%。     

阿莫西林颗粒剂

本品含羟氨苄青霉素(C₁₆H₁₉N₃O₅S)应为标示量的90.0~110.0%。     

国家食品药品监督管理局国家药品标准修订件——氨苄西林胶囊

本品含氨苄西林(C₁₆H₁₉N₃O₄S)应为标示量的90.0%~110.0%。     

国家食品药品监督管理局国家药品标准修订件——氨苄西林颗粒

本品含氨苄西林(C₁₆H₁₉N₃O₄S)应为标示量的90.0%~110.0%。     

国家食品药品监督管理局国家药品标准补充颁布件——奥美拉唑镁肠溶片

本品含奥美拉唑镁按奥美拉唑(C₁₇H₁₉N₃O₃S)计算,应为标示量的90.0%~110.0%。     

头孢拉定颗粒剂

本品含头抱拉定(C₁₆H₁₉N₃O₄S)应为标示量的90.0%~120.0%。     

国家食品药品监督管理局国家药品标准修订件——甲磺酸酚妥拉明片

本品含甲磺酸酚妥拉明(C₁₇H₁₉N₃O·CH₄O₃S)应为标示量的93.0%~107.0%。     

国家食品药品监督管理局国家药品标准修订件——甲磺酸酚妥拉明胶囊

本品含甲磺酸酚妥拉明(C₁₇H₁₉N₃O·CH₄O₃S)应为标示量的93.0%~107.0%。     

Fondaparinux Sodium Compared with Enoxaparin Sodium

INTRODUCTION: Patients undergoing major orthopedic surgery face considerable risk of venous thromboembolism (VTE), which may be fatal unless they receive prophylactic treatment. Fondaparinux sodium is a new antithrombotic agent that is indicated for prophylaxis of VTE after major orthopedic surgery. This paper presents a cost-effectiveness analysis of fondaparinux sodium and enoxaparin sodium, the latter being the most commonly used agent for prophylaxis of VTE. METHODS: The analysis is based on an international simulation model, using Norwegian unit costs, and Norwegian data of 55 000 patients undergoing orthopedic surgery between 1999 and 2001. We estimated the expected incidence of VTE and VTE-related deaths, and expected costs of VTE-related care for each of the two prophylactic agents for different periods. RESULTS AND CONCLUSION: The results indicate that fondaparinux sodium is likely to be more effective than enoxaparin sodium in preventing the incidence of VTE. By day 90, fondaparinux sodium is expected to avoid 180 more VTE events, and between 8 and 33 more VTE-related deaths per 10,000 patients than enoxaparin sodium. Fondaparinux sodium is also a cost-saving option in short follow-up periods for hip fracture surgery. For extended follow-up periods (i.e. 5 years), fondaparinux sodium is also likely to represent the lower cost treatment option after total knee and hip replacement. The sensitivity analyses show that the main results are robust to changes in the most important parameters. Results are, however, sensitive to the price difference between the two drugs.     

注射用他唑巴坦钠/哌拉西林钠

本品为哌拉西林钠和他唑巴坦钠组成的复方制剂。哌拉西林为广谱半合成着霉素类抗生素，他唑巴坦为β-内酰胺酶抑制剂。本品适用于对哌拉西林耐药，但对哌拉西林／他唑巴坦敏感的产β-内酰胺酶的细菌引起的中、重度感染，其抗菌谱包括革兰氏阴性菌、革兰氏阳性菌及厌氧菌。     

国家食品药品监督管理局国家药品标准修订件——注射用阿莫西林钠舒巴坦钠

本品为白色或类白色粉末或结晶性粉末,极易引湿。     

HPLC法测定头孢哌酮钠/舒巴坦钠中头孢哌酮钠的胆药浓度

目的:建立头孢哌酮钠/舒巴坦钠中头孢哌酮钠胆药浓度的测定方法。方法:于腹腔镜胆囊切除手术中胆囊取胆汁标本,用高效液相色谱法测定胆清中头孢哌酮钠的浓度,其中色谱柱为YWGC18,流动相为甲醇-水-冰醋酸(25.5∶74.5∶0.45),流速为1.0mL.min-1,柱温为35℃,检测波长为254nm。结果:头孢哌酮胆汁浓度在1.25~62.5μg.mL-1范围内线性关系良好(r=0.9991);平均回收率为95.14%(RSD=3.42%)。结论:本方法简便、可靠,可为临床合理用药提供依据。     

Fondaparinux Sodium

Fondaparinux sodium (fondaparinux) is a synthetic sulfated pentasaccharide anticoagulant developed from the antithrombin binding moiety of heparin. Through the activation of antithrombin it inhibits Factor Xa, the activation of thrombin, and the subsequent coagulation cascade. Fondaparinux is approved in Europe and the US for the treatment of acute venous thromboembolism (VTE), including both deep vein thrombosis (DVT) and pulmonary embolism (PE), when used in conjunction with warfarin. In phase III clinical trials, subcutaneous fondaparinux was noninferior to subcutaneous enoxaparin or intravenous unfractionated heparin (UFH) in the prevention of recurrent symptomatic VTE in patients with acute DVT and PE, respectively, and equally well tolerated. It thus provides a valuable alternative to UFH and low-molecular weight heparins in the treatment of acute VTE, particularly in the outpatient setting.     

Fondaparinux Sodium

Fondaparinux sodium (Arixtra) is a synthetic, sulfated pentasaccharide, selective factor Xa inhibitor that is indicated in Europe for preventing thrombus formation in patients with acute coronary syndromes (ACS; the focus of this review), including those with ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), or unstable angina.The large (n = 20,078), well designed OASIS-5 trial showed that subcutaneous fondaparinux 2.5 mg/day for 12,000) OASIS-6 trial. There were no differences in the incidence of major bleeding between these groups, resulting in a benefit : risk balance favoring fondaparinux. The specificity and selectivity of fondaparinux, combined with its long half-life and 100% bioavailability, allows once-daily anticoagulation without the need for monitoring activated clotting time. Subcutaneous fondaparinux was noninferior to enoxaparin treatment in patients with unstable angina or NSTEMI, and was more effective than usual care in those with STEMI. Fondaparinux has a favorable tolerability profile, particularly with regard to the risk of major bleeding, and limited data suggest that it is more cost effective than enoxaparin in the short term. Thus, overall, clinical evidence suggests that fondaparinux has a valuable place in the treatment of patients with ACS.     

国家食品药品监督管理局国家药品标准修订——萘夫西林钠

本品为(2S,5R,6R)-6-(2-乙氧基-1-萘甲酰胺基)-3,3-二甲基-7-氧-4-硫杂-1-氮杂双环[3.2.0]庚烷-2-甲酸-钠-水合物。按无水物计算,含萘夫西林(C₂₁H₂₂N₂O₅S)不得少于85.5%。     

国家食品药品监督管理局国家药品标准修订件——甘氨双唑钠

本品为类白色至微黄色的结晶或结晶性粉末;无臭,味苦;遇光色渐变深。